Myelodysplastic Syndrome Clinical Trial
ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.
The study consisted of a 4-week Screening Period and a 26-week Randomized Treatment Period (Primary Evaluation Period). After completion of the Primary Evaluation Period, all participants had the opportunity to enter the Extension Period, wherein participants will receive ravulizumab for up to 3 years.
The data presented is up to the Primary Completion date of the study and is for the Primary Evaluation Period. The results for the Extension Period will be reported after study completion.
Male or female ≥18 years of age.
Treated with eculizumab for PNH for at least 6 months prior to Day 1.
Lactate dehydrogenase level ≤1.5 times the upper limit of normal (ULN) at screening.
PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
Documented meningococcal vaccination not more than 3 years prior to, or at the time of, initiating study treatment.
Female participants of childbearing potential must use highly effective contraception starting at screening and continuing until at least 8 months after the last dose of ravulizumab.
Willing and able to give written informed consent and comply with study visit schedule.
History of bone marrow transplantation.
Body weight <40 kilograms at screening.
History of or ongoing major cardiac, pulmonary, renal, endocrine, or hepatic disease that, in the opinion of the investigator or sponsor, would preclude participation.
Unstable medical conditions (for example, myocardial ischemia, active gastrointestinal bleeding, severe congestive heart failure, anticipated need for major surgery within 6 months of randomization, or coexisting chronic anemia unrelated to PNH).
Female participants who are pregnant, breastfeeding, or who have a positive pregnancy test at screening or Day 1.
Participation in another interventional clinical study or use of any experimental therapy within 30 days before initiation of study treatment on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 49 Locations for this study
Duarte California, 91010, United States
Los Angeles California, 90033, United States
Baltimore Maryland, 21205, United States
Detroit Michigan, 48202, United States
Bronx New York, 10467, United States
Canberra Australian Capital Territory, 2605, Australia
Kogarah New South Wales, 2217, Australia
Liverpool New South Wales, 2170, Australia
Woolloongabba Queensland, 4102, Australia
Parkville Victoria, 3050, Australia
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Montréal Quebec, H1T 2, Canada
Amiens , 80054, France
Marseille , 13273, France
Paris , 75475, France
Pierre-Bénite , 69495, France
Saint-Priest-en-Jarez , 42271, France
Strasbourg , 67091, France
Ulm Baden Wuerttemberg, 89081, Germany
Aachen Nordrhein Westfalen, 52074, Germany
Essen Nordrhein Westfalen, 45147, Germany
Firenze , 50134, Italy
Milano , 20122, Italy
Napoli , 80131, Italy
Torino , 10126, Italy
Vicenza , 36100, Italy
Kanazawa-shi Ishikawa, 920-8, Japan
Suwa Nagano, 392-8, Japan
Suita-shi Osaka, 565-0, Japan
Shinagawa-Ku Tokyo, 141-8, Japan
Fukushima , 960-1, Japan
Daegu , 42415, Korea, Republic of
Daejeon , 35015, Korea, Republic of
Gyeonggi-do , 14584, Korea, Republic of
Gyeonggi-do , 16247, Korea, Republic of
Incheon , 21565, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Maastricht , 6229, Netherlands
Nijmegen , 6525, Netherlands
Barcelona , 08036, Spain
Madrid , 28040, Spain
Majadahonda , 28222, Spain
Airdrie , ML6 9, United Kingdom
Leeds , LS9 7, United Kingdom
London , SE5 9, United Kingdom
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.